The Efficacy of Exercise Therapy in Patients With Inflammatory Bowel Disease

NCT ID: NCT05455762

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2022-11-30

Brief Summary

this study aims to determine the effect of 8 weeks of exercise on the quality of life and muscle strength of patients with IBD. Patients will be randomized into 1) Intervention group: doing aerobic and resistance exercise according to physiotherapist prescription and 2) Control group: usual medical care. Both groups will continue their medications prescribed by the Gastroenterologist. After 8 weeks patients come back to the hospital for reevaluation of measured indices. The primary outcome of this study is the patient quality of life assessed by the IBDQ questionnaire. Other outcomes that will be evaluated before and after 8 weeks are muscle strength measured by a dynamometer and laboratory markers such as ESR and CRP and tool calprotectin. Also, disease activity using partial mayo score and Harvey Bradshaw score will be calculated and compared before and after treatment.

Detailed Description

Inflammatory bowel disease has a huge burden both on patients and on the health system due to its chronic nature. Studies have shown a higher prevalence of sarcopenia, a condition in which muscle mass and strength decreases, in patients with IBD compared to age and sex-matched healthy individuals. Patients with IBD are physically less active than the normal population according to a couple of researches. There has been a growing interest to evaluate the effect of exercise on the quality of life and disease severity of IBD patients in recent years.

This study aims to determine the effectiveness of combined aerobic and resistance exercise on quality of life, physical function, muscle strength, disease activity, and laboratory markers in patients with established IBD.

The researchers will invite 56 patients to the Imam Khomeini hospital complex, Tehran, Iran. All patients will be enrolled after taking informed consent. Interventions will be conducted with the coordination of the patient's physician. Patients will be randomized to the intervention or control group. Outcome measurements will be evaluated immediately before and after the interventions (8 weeks period)

Conditions

Inflammatory Bowel Diseases; Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise group

patients in this group will participate in an 8 week program of exercise. The exercise program includes both aerobic and resistance exercise. The patients will exercise 6 days a week,3 days aerobic exercise and 3 days resistance ones. The aerobic exercise consists of 20 minutes walking. Patients will walk slowly in the first five minutes to warm up, then they walk faster and with the intensity prescribed by the physiotherapist. In the last 5 minutes the patient will walk like the first 5 minutes. The middle 10 minutes may be increased or not based on patients' weekly self-report. The resistance training include hip abduction, shoulder abduction, bridging, elbow flexion and knee extension. each of these exercises is done in 3 set of 10 repetition with one minute break between each set. Based on patients' weekly report a 0.5 kilogram weight might be added.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

The intervention consists of 8 week of combined resistance and aerobic exercise. Patients will exercise 6 days a week;3 days aerobic ones and 3 days resistance ones. The aerobic exercise include 20 minutes of walking divided into three parts. In the first five minute the patients walks slowly to warm up, in the next 10 minutes the patient will speedup to reach the intensity described by the physiotherapist. In the last 5 minutes the patient walks like the first five minutes. The middle 10 minutes may be increased or not based on patient's weekly report. The resistance training consists of 5 exercise; hip abduction, shoulder abduction, bridging, elbow flexion and knee extension. each of these exercises is done in 3 set of 10 repetition with one minute break between each set. Based on patients' weekly report a 0.5 kilogram weight might be added.

Control group

The patients in this group will continue their routine life and treatment prescribed by the gastroenterologist for their condition

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

The intervention consists of 8 week of combined resistance and aerobic exercise. Patients will exercise 6 days a week;3 days aerobic ones and 3 days resistance ones. The aerobic exercise include 20 minutes of walking divided into three parts. In the first five minute the patients walks slowly to warm up, in the next 10 minutes the patient will speedup to reach the intensity described by the physiotherapist. In the last 5 minutes the patient walks like the first five minutes. The middle 10 minutes may be increased or not based on patient's weekly report. The resistance training consists of 5 exercise; hip abduction, shoulder abduction, bridging, elbow flexion and knee extension. each of these exercises is done in 3 set of 10 repetition with one minute break between each set. Based on patients' weekly report a 0.5 kilogram weight might be added.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients with IBD (UC or Chron's) confirmed by colonoscopy and pathology

2. Be able to read and write in Farsi

3. Be able to participate to exercise therapy program.

Exclusion Criteria

1. Patients with PSC

2. Patients with cirrhosis

3. Patients with colon cancer

4. Patients on corticosteroid treatment

5. Patients' dissatisfaction to continue the study for any reason

6. Patients who exercise on a daily routine (more than 30 minutes per day)

7. Patients having any contraindication for exercise training.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Mohammad Javaherian

Dr. Mohammad Javaherian

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Foroogh Alborzi, M.D.

Role: STUDY_CHAIR

Tehran University of Medical Sciences, Imam Khomeini hospital complex

Saeed Mirmoosavi, M.D. Student

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Mohammad Javaherian, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Locations

Imam Khomeini Hospital Complex

Tehran, , Iran

Countries

Iran

Central Contacts

Mohammad Javaherian, Ph.D.

Role: CONTACT

Javaherian_m@razi.tums.ac.ir

+989129321391

Facility Contacts

Forough Alborzi

Role: primary

Other Identifiers

9511215137

Identifier Type: -

Identifier Source: org_study_id